BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 17015367 · Received May 26, 2023

    Report

    Report Number
    9681834-2023-00106
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    UDI-DI
    04987350763471
    PMA / PMN Number
    K022115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, UNKNOWN. DATE OF BIRTH: REQUESTED, UNKNOWN. PATIENT SEX: REQUESTED, UNKNOWN. WEIGHT: REQUESTED, UNKNOWN. ETHNICITY: REQUESTED, UNKNOWN. RACE: REQUESTED, UNKNOWN. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. ADDRESS: REQUESTED, UNKNOWN. ZIP CODE: REQUESTED, UNKNOWN. TELEPHONE NUMBER: REQUESTED, UNKNOWN. PMA/510(K): K130493. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. RECORD REVIEW: PROVIDED IMAGE: IT WAS FOUND THAT BLOOD WAS ADHERED TO THE GAS OUTLET PORT OF OXYGENATOR. HOWEVER, IT WAS NOT POSSIBLE TO IDENTIFY THE LOCATION OF LEAKAGE FROM THE IMAGE. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT: NO ANOMALY WAS FOUND. PAST COMPLAINT FILE: NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT# WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD OF THE ACTUAL PRODUCT. SINCE THE ACTUAL SAMPLE COULD NOT BE INVESTIGATED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IFU STATES: : "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX RX05 OXYGENATOR AND RESERVOIR." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT BLOOD SLOWLY DRIPS FROM THE GAS OUTLET DURING CPB, THE ENTIRE CPB PROCEDURE TAKES ABOUT ONE HOUR WITH A TOTAL OF SEVEN TO EIGHT DROPS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848943 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 220510 04987350763471

    Patients

    Seq Age Sex Outcome Treatment
    1 103 DA Unknown